The following data is part of a premarket notification filed by Penlon Ltd. with the FDA for Prima Anaesthesia Machine.
| Device ID | K061102 |
| 510k Number | K061102 |
| Device Name: | PRIMA ANAESTHESIA MACHINE |
| Classification | Gas-machine, Anesthesia |
| Applicant | PENLON LTD. Abingdon Science Park Barton Lane, Abingdon, GB Ox14 3nb |
| Contact | Barry Pearce |
| Correspondent | Barry Pearce PENLON LTD. Abingdon Science Park Barton Lane, Abingdon, GB Ox14 3nb |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-19 |
| Decision Date | 2006-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051977000079 | K061102 | 000 |
| 05051977000031 | K061102 | 000 |
| 05051977000024 | K061102 | 000 |
| 05051977000017 | K061102 | 000 |
| 05051977000000 | K061102 | 000 |
| 00815871020084 | K061102 | 000 |
| 00815871020077 | K061102 | 000 |
| 00815871020060 | K061102 | 000 |